Convalescent Plasma in Pediatric COVID-19
Purpose
COVID-19 is increasingly affecting children but convalescent plasma (CP) has not been adequately studied in children to date. The study will determine safety of convalescent plasma for pediatric patients with severe, or at high risk for severe, COVID-19 disease.
Condition
- COVID
Eligibility
- Eligible Ages
- Between 0 Years and 22 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Aged 0 to 22 years of age - SARS-CoV-2 infection documented by RNA RT-PCR detection - Admitted to an acute care facility - Ability of patient or guardian to provide consent and assent (if applicable); if patient is intubated assent may be waived
Exclusion Criteria
- Pregnancy/ breast feeding - Medical condition that increases the risk of plasma infusion - Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products). Inclusion criteria for infusion: - Severe COVID-19 disease, OR - Moderate disease with a risk of progression to severe or life threatening disease, OR - Severely immunocompromised patient with any illness attributed to COVID-19 disease requiring inpatient care. Exclusion to infusion: - Pregnancy/ breast feeding - Medical condition that increases the risk of plasma infusion - Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products).
Study Design
- Phase
- Early Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Convalescent Plasma (CP) |
Once the patient meets criteria for CP infusion (severity of disease and risk factor determination and absence of exclusion criteria) convalescent plasma will be administered |
|
Recruiting Locations
More Details
- NCT ID
- NCT04458363
- Status
- Completed
- Sponsor
- Emory University
Detailed Description
COVID19 is an emerging infection with no current approved treatment or prevention. COVID-19 is increasingly affecting children but convalescent plasma (CP) has not been adequately studied in children to date. The study will determine safety of convalescent plasma for pediatric patients with severe, or at high risk for severe, COVID-19 disease.